Atlas FDA

COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE

FDA 510(k) clearance K140695 · decided 2014-06-12

Clearance details

K-number
K140695
Device name
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2014-03-19
Decision date
2014-06-12
Days to decision
85 days
Clearance type
Traditional
Product code
DQX
Device class
2
Regulation number
870.1330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Danvers, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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